Last Friday, a new drug that has been shown to reduce cognitive decline associated with Alzheimer’s disease was endorsed by a Food and Drug Administration Advisory Committee. While this is a step forward, the treatment is not a cure and it does have side effects.
Here’s what you need to know.
Lecanemab – marketed as Leqembi by the Eli Lilly Company – is a “humanized IgG1 monoclonal antibody,” a type of man-made antibody formulated to work like antibodies made by the human immune system. FDA accelerated approval was granted for the drug in January.
According to study results published in The New England Journal of Medicine, lecanemab binds with amyloid-beta soluble protofibrils. This is important because “accumulation of soluble and insoluble aggregated amyloid-beta,” is associated with the development of Alzheimer’s, per the study.
Deposits of beta-amyloid that build up in the spaces between nerve cells are called plaques. These are found in predicable patterns in the brains of Alzheimer’s patients, along with tangles, according to the Alzheimer’s Association. Symptoms of the disease include memory loss, confusion and mood changes, as well as disorientation difficulty speaking, talking and walking.
A March report from the Alzheimer’s Association found that an estimated 6.7 million adults in the U.S. have the Alzheimer’s, and that number is expected to grow.
Results of an 18-month clinical trial with 1,795 participants indicated that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo.”
However, this trial also indicated that the drug “was associated with adverse events,” and, according to the Alzheimer’s Association, lecanemb and anti-amyloid treatments in this class of drug can cause “amyloid-related imaging abnormalities (ARIA), which usually do not cause symptoms, but can be serious.”
Still, the Alzheimer’s Association and the FDA believe that results indicate that lecanemab could be be beneficial to patients. Aduhelm, a drug that was approved by the FDA in 2021, is also associated with ARIA risk.
“While the thought of a cure for Alzheimer's disease is certainly part of my optimism, I’d like you to know that for me, more time is enough for now. And that is the promise of treatments like lecanemab,” said Myra Garcia, a member of the Alzheimer's Association Early Stage Advisory Group, to the Peripheral and Central Nervous System Drugs Advisory Committee last week.
“We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
There are still some hoops to jump through before lecanamab gets FDA approval. Next, the FDA will put the drug through a review process, and the association said action is required from the agency by July 6.
“By slowing progression in the early stages of Alzheimer’s, this treatment will give people more time to participate fully in daily life, participate in important decisions, and live independently,” said the Alzheimer’s Association. “This could mean more time for a person to take care of family finances, and participate in hobbies and interests.”
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